Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reported: September 24, 2025 Initiated: September 4, 2025 #D-0657-2025
Product Description
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason for Recall
Failed Impurity/Degradation Specifications
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 4440 bottles
- Distribution
- U.S. Nationwide
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 4440 bottles.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2025. Severity: Moderate. Recall number: D-0657-2025.
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